"It is outrageous that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes every citizen in the United States a potential "guinea pig," without providing a practical, informative warning to the public."
The statement of outrage above was included in a letter to acting FDA Commissioner, Dr von Eschenbach, from Senator Charles Grassley (R-Iowa) on February 24, 2006. Senator Grassley has been keeping a close eye on the performance of the FDA in recent years.
As a Senator representing the State of Iowa and Chairman of the Committee on Finance, which has jurisdiction over the Medicare and Medicaid programs, the Senator wrote, "I am responsible for oversight of matters that affect my constituents and the beneficiaries of these federal health care programs."
In the letter, he advised Dr von Eschenbach that he found a recent Wall Street Journal article titled, "Amid Alarm Bells, A Blood Substitute Keeps Pumping," alarming.
According to Sen Grassley, the WSJ says the FDA is allowing Illinois-based Northfield Laboratories to test a blood substitute called PolyHeme, in a clinical trial without the consent of patients, who may be unconscious or otherwise incapable of providing informed consent, pursuant to a rarely used FDA regulation, which allows for waiver of the consent required in clinical trials, if some type of community outreach program is put into practice.
"I understand the value of a viable blood substitute," Senator Grassley told Dr von Eschenbach in the letter, "but I’m really disturbed by what I’m hearing about the FDA’s role here and I want to find out what’s going on."
PolyHeme contains hemoglobin processed from expired blood donations and is designed to be given to trauma victims in place of blood or saline solution. The product is supposed to be used as a temporary measure when there is a large blood loss and no readily available blood supply, according to Northfield.
Under guidelines for emergency teams participating in the study, at trauma sites, they administer PolyHeme to half of the patients, and standard saline solution to the other half. At the emergency room, patients who get PolyHeme at the trauma site continue to receive PolyHeme.
The 1996 federal regulation in question allows trials of possible life-saving treatments without patient consent if participating facilities inform members of the community about the trial and gauge public sentiment.
"I am skeptical," Sen Grassley told the FDA, "that any participating medical centers managed to conduct effective, practical outreach to the community and to provide a meaningful, informative warning to the public about the PolyHeme Study."
"If you’re in a car accident, of course you want emergency doctors to save your life," Sen Grassley said in a press release. "But no reasonable person would expect to be treated as an experimental subject without consent," he added.
The trial is currently being conducted in 18 states that include California, Colorado, Delaware, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Virginia
So if you travel in these states and suffer a traumatic injury or need emergency treatment at a participating trauma center, you could become an unknowing research subject without your consent.
That is, unless you happen to be wearing a lightblue wristband imprinted with the statement: "I decline the Northfield PolyHeme Study."
This silly provision has further angered the Senator. "The idea that the FDA would put the burden on the public to opt out of this mass experiment is outrageous," he said.
An unknown number of community meetings were reportedly held in participating states and anyone who took time to attend a meeting could opt out by wearing continuously for an undetermined period of time one of these light-blue wristbands.
"Why should Americans have to wear a bracelet at all times to protect themselves from a government-sanctioned medical experiment if they happen to get into a car accident?" he asked the FDA.
"I suspect many people, if they knew this," Senator Grassley noted, "might reasonably ask, "where do I get my wristband?"
This question is not readily answerable according to the Senator, "it’s not apparent from any information on the FDA’s website," he said.
Researchers at Legacy Health System and Oregon Health & Science University in Portland, Oregon suspended their plans to test the blood substitute after attempts to get local approval for the experiment were unsuccessful for 2 years.
The WSJ reported that, in an earlier clinical trial of PolyHeme, 10 out of 81 patients suffered heart attacks within a week of receiving the substitute and that 2 of those people died.
Besides the heart attacks and deaths, the trial suggested the PolyHeme was linked with other adverse events such as heart rhythm aberrations and pneumonia. These events occurred in 54% of the PolyHeme patients versus 28% in the control group, according to Northfield’s internal documents.
The previous study differs from the current study in that patients in the first study were not trauma patients, they were undergoing surgery to repair aneurysms in their aortas and consented to participating in the study. In the first study, patients in one group received PolyHeme and patients in the control group received real blood.
In the second half of 2001, "Northfield abruptly shut down the study, explaining in a Securities and Exchange Commission filing that it was taking too long to complete," the WSJ reports. The paper says Northfield failed to make the results of the study public.
Northfield’s chief executive, Steven Gould, says it has not been proven that the adverse events in the trial were caused by PolyHeme and claims the heart attacks may have been caused by doctors who pumped too much fluid into patients, when adding PolyHeme and real blood.
William Hoffman, chief of the cardiac-surgery intensive-care unit at Massachusetts General Hospital in Boston, told the WSJ that substitutes in a class that includes PolyHeme, are associated with heart attacks and strokes. "It is self-serving and potentially misleading to associate harmful effects with something other than the test drug," he said.
Doctors who took part in the first study have questions but said Northfield restricted access to the full data so they only knew what happened to their own patients.
At the University of Pennsylvania, Dr. Fairman told the WSJ that he and a colleague, Albert Cheung, repeatedly called Dr Gould at Northfield. "We said, ‘Let’s sit down and write up the data,’ " Dr. Fairman recalls. "He wouldn’t do it."
Dr. Cheung proposed a meeting of doctors at the 21 hospitals that had taken part in the study and says Dr Gould agreed to the meeting, but then cancelled it at the last minute.
T.J. Gan, a Duke University anesthesiologist involved in the study, told the WSJ he called Northfield three years ago to ask if results had been published and Dr. Gould told him, "Someone’s working on it."
Northfield issued a statement saying company officials do not recall the specifics of any discussion about a meeting with Dr Cheung or the conversation with Dr Gan. It denies that it "resisted publication" but says: "We did not allocate resources to publication. In retrospect, reporting the full study results earlier would have been better."
"Last year," according to the WSJ, "the FDA required Northfield to mention on its Web site "serious cardiovascular adverse experiences" with PolyHeme."
"Five of the 31 hospitals in the trauma study followed suit, but well after many trauma patients had been treated," the paper noted.
In his letter, Senator Grassley told the FDA to address the issue "by providing the public with meaningful information related to what it should already have known about the PolyHeme Study."
In addition, by March 8, 2006, he instructed the agency to provide his Committee with a detailed briefing regarding the study.
"Over the next few days," Senator Grassley wrote, "my Committee staff will contact your staff with more specific requests for information, but at the minimum your staff should be prepared to address the following issues related to the PolyHeme Study:
1. What oversight, if any, has FDA conducted related to the PolyHeme Study?
2. What consultation with representatives of the community was conducted?
3. What public disclosure to communities was conducted prior to initiation of the PolyHeme Study?
4. Were known adverse events, including but not limited to those reported in the WSJ, disclosed with the risks and expected benefits information?
5. Has Northfield Laboratories, Inc., met all regulatory reporting requirements related to its PolyHeme product, including but not limited to timely reporting of all adverse events?"
He also asked the FDA to provide a detailed list and summary of all clinical trials conducted since January 1, 1996, under the FDA regulation governing exception from informed consent requirements.
In regard to the current study, Northfield says an independent committee monitoring the study reviewed reports of death and other serious problems four times, and each time recommended the trial continue unchanged, according to Reuters News on February 24, 2006.
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